Reported Oct 29, 2014 · Terminated
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to…
Aerogen Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aerogen Ltd. · Galway Business Park · Galway · N/A
Is this the product you have?
- The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
- Lot codes and dates
22 of 22 products
Products covered by this recall Model / number Barcodes Product as published AG-AP1040-AU800314051905780031407080158003140722089Lot Numbers: 8003140519057 , 8003140708015 , 8003140722089 AG-AP1040-EU80014073112480001405200748000140520087800014052008780001405301038000140619082800014062009280001406241038000140624118800014070110480001407021538000140721056800014072609780001407281008000140728117800014072812080001406251008000140624100Lot Numbers: 800140731124 , 8000140520074 , 8000140520087 , 8000140520087 , 8000140530103 , 8000140619082 , 8000140620092 , 8000140624103 , 8000140624118 , 8000140701104 , 8000140702153 , 8000140721056 , 8000140726097 , 8000140728100 , 8000140728117 , 8000140728120 , 8000140625100, 8000140624100 AG-AP1040-UK80011405190678001140624115800114071404480011407280658001140731125Lot Numbers: 8001140519067 , 8001140624115 , 8001140714044 , 8001140728065 , 8001140731125 AG-AP1040-US8002140520090800214052108880021405220918002140522093800214052309480021405230958002140526114800214052709680021406031218002140603130800214061306780021406130688002140616069800214061607080021406261238002140627124800214062712580021406271388002140711036800214071404280021407210858002140721087800214072209180021407220928002140722093Lot Numbers: 8002140520090 , 8002140521088 , 8002140522091 , 8002140522093 , 8002140523094 , 8002140523095 , 8002140526114 , 8002140527096 , 8002140603121 , 8002140603130 , 8002140613067 , 8002140613068 , 8002140616069 , 8002140616070 , 8002140626123 , 8002140627124 , 8002140627125 , 8002140627138 , 8002140711036 , 8002140714042 , 8002140721085 , 8002140721087 , 8002140722091 , 8002140722092 , 8002140722093 AG-AP1500-IN9948140702153Lot Numbers: 9948140702153 AG-AP1500-UK9953140801132Lot Numbers: 9953140801132 AG-AP1500-US99391405220919939140630138Lot Numbers: 9939140522091 , 9939140630138 AG-AP60009998140611025(DG)-FR; Lot Numbers: 9998140611025 AG-AP60009997140611024(DG)-GE; Lot Numbers: 9997140611024 AG-AP60009996140728059(DG)-IN; Lot Numbers: 9996140728059 AG-AP6000-AU99151407220569915140722089Lot Numbers: 9915140722056 , 9915140722089 AG-AP6000-CH99661405210219966140624102Lot Numbers: 9966140521021 , 9966140624102 AG-AP6000-FR9905140521074990514052610899051406100239905140731072Lot Numbers: 9905140521074 , 9905140526108 , 9905140610023 , 9905140731072 AG-AP6000-GE99041405191419904140520089990414062610099041407021499904140726097Lot Numbers: 9904140519141 , 9904140520089 , 9904140626100 , 9904140702149 , 9904140726097 AG-AP6000-IN991314052002699131405260779913140526102991314060308399131406090099913140617074991314062411799131407031609913140703160991314070316499131407040229913140709028991314070902999131407111529913140721008991314072105799131407210789913140728104991314072811199131408011299913140805137991314060409799131406030979913140609129991314060312999131407240049913140725004991314072900499131407280049913140723004Lot Numbers: 9913140520026 , 9913140526077 , 9913140526102 , 9913140603083 , 9913140609009 , 9913140617074 , 9913140624117 , 9913140703160 , 9913140703160 , 9913140703164 , 9913140704022 , 9913140709028 , 9913140709029 , 9913140711152 , 9913140721008 , 9913140721057 , 9913140721078 , 9913140728104 , 9913140728111 , 9913140801129 , 9913140805137 , 9913140604097, 9913140603097 , 9913140609129, 9913140603129, 9913140724004, 9913140725004, 9913140729004, 9913140728004, 9913140723004 AG-AP6000-IT99061405150239906140710033Lot Numbers: 9906140515023 , 9906140710033 AG-AP6000-NO9916140519058Lot Numbers: 9916140519058 AG-AP6000-RU99681407041669968140721077Lot Numbers: 9968140704166, 9968140721077 AG-AP6000-SP99071405190289907140730097Lot Numbers: 9907140519028 , 9907140730097 AG-AP6000-SW9927140607011Lot Numbers: 9927140607011 - Amount recalled
- 2,421 power adapters
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.
This product could cause temporary or reversible health problems — stop using it.
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